COMPAX 40E
Received Apr 17, 2008 · Event occurred Jan 15, 2008
Report 2126677-2008-00029 · MDR key 1031362
Device
Product problems
- Locking mechanism failure
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE COMPAX 40E TABLE LOCKS WERE NOT HOLDING, CAUSING THE TABLE TO MOVE FREELY IN ALL AXIS. THERE WAS NEITHER INJURY REPORTED NOR PT INVOLVEMENT. THE CONCERN IS FOR A SERIOUS INJURY IF A PT WERE TO BECOME UNSTEADY AND FALL AS RESULT OF THE FREE TABLE MOVEMENT.
Additional Manufacturer Narrative
A GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND DEBRIS UNDER THE LEFT FOOT PEDAL, WHICH PREVENTED THE LOCKING MECHANISM FROM ENGAGING. THE FE CLEANED THE FOOT PEDAL ASSEMBLY, ADJUSTED THE SWITCH ON THE LEFT PEDAL, AND VERIFIED TABLE LOCK FUNCTIONALITY. PROCEDURES ARE CURRENTLY IN PLACE PER THE PREVENTATIVE MAINTENANCE MANUAL TO INSPECT THE CONDITION AND FUNCTIONALITY OF CONTROL PEDALS AND MOVEMENT INHIBIT BUTTON.